Comparison of ISO Standards for Device Performance; 20072 and 27427: A Critical Appraisal
Bibliographic record
Abstract
Two separate international standards, ISO 20072:2009 and ISO 27427:2010, have recently been published that relate to the development and performance testing of oral inhaled products (OIPs). The scope of ISO 20072 encompasses all OIP forms except nebulizing systems, whereas ISO 27427 was developed specifically for this class of OIP. Compliance with these standards will likely be necessary for manufacturers seeking approval to market inhaler devices in the European Union (EU). Their adoption in the United States may take a considerable time, but the FDA has expressed support in general terms for the ISO process. Key aspects of both standards that are very different in style and content are identified and discussed from the perspective of a potential user. In the approach adopted by ISO 20072, a formalized risk assessment is undertaken as a key part of design verification, in order to develop the Device Functionality Profile (DFP) of the device. The DFP is subsequently verified by the System Verification Test (SVT), in which pharmacopeial test methods are used to evaluate in vitro performance of the device with a chosen drug product in a statistically robust manner. On the other hand, ISO 27427 adopts a more prescriptive approach that involves performance verification of the finished nebulizing system using 1% w/v salbutamol as the test formulation. Although ISO 27427 is currently undergoing revision, at present it is unclear whether the changes that are made will significantly alter its fundamentally different approach to device performance verification. A strong case can be made for a single OIP-wide ISO standard, based on the principles developed in ISO 20072 and that makes use of the well-understood and validated in vitro test procedures that are available or will shortly be available in the case of nebulizing systems, in the United States and European pharmacopeias.
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How this classification was reachedexpand
Full frame machine prediction
Teacher imitationNot calibrated prevalence, not ground truth. Human validation pending. The Gemma side is a direct model label for every work in the frame, read from the title-only record. The Codex side is a classifier learned from the 10,348 direct Codex labels and calibrated to design-weighted sample rates; fields without enough sample support carry no Codex call. Candidate is the union of the two sides; consensus is their intersection. These outputs are machine_predicted_unvalidated and are not human labels.
Distilled classifier scores by category (both heads)
| Category | Codex | Gemma |
|---|---|---|
| Metaresearch | 0.282 | 0.295 |
| Meta-epidemiology (narrow) | 0.003 | 0.002 |
| Meta-epidemiology (broad) | 0.004 | 0.007 |
| Bibliometrics | 0.030 | 0.015 |
| Science and technology studies | 0.003 | 0.005 |
| Scholarly communication | 0.013 | 0.006 |
| Open science | 0.009 | 0.004 |
| Research integrity | 0.007 | 0.006 |
| Insufficient payload (model declined to judge) | 0.004 | 0.003 |
Machine scores (provisional)
The two teacher heads of the student model, read on this work. A score orders the frame for review; it never asserts a category, and the validation status ships verbatim with every row.
Baseline scores from an immature model (maturity gate not passed, 7 training rounds). Scores rank; they never assert a category.
score_only:v0-immature-baseline · verbatim from the scoring run: score_only means the number may rank works, and no category label ships from itClassification
machine, unvalidatedMachine predicted; a candidate call from one source (direct Gemma or distilled Codex), not a consensus.
How this classification was reached, model by model and score by score, is at the end of the page under "How this classification was reached".